DXA body composition and bone mineral density review and analyses for the Healthy Aging in Neighborhoods of Diversity across the Life Span study

Notice Type: Presolicitation Notice

Posted Date: 29-MAR-19

Office Address: Department of Health and Human Services; National Institutes of Health; National Institute on Drug Abuse; 6001 Executive BoulevardRoom 4211, MSC 9559 Bethesda MD 20892-9559

Subject: DXA body composition and bone mineral density review and analyses for the Healthy Aging in Neighborhoods of Diversity across the Life Span study

Classification Code: B - Special studies and analysis - not R&D

Solicitation Number: HHS-NIH-NIDA(AG)-RFQ-75N95019R00034

Contact: Heather Orandi, Contract Specialist, Phone 3014436162, Email [email protected]

Setaside: N/AN/A

Place of Performance Country: US

Description: Department of Health and Human Services

National Institutes of Health

National Institute on Drug Abuse

The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to award a requirement titled: DXA body composition and bone mineral density review and analyses for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study. This procurement is being competed under full and open competitive procedures. It is anticipated that a single cost reimbursement type contract will be awarded on/abount June 24, 2019.

BACKGROUND

The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a multidisciplinary, community-based, prospective longitudinal epidemiologic NIA study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. This study is unique because it will assess over 20-years physical parameters as well as evaluate genetic, biologic, demographic, psychosocial, and psychophysiological parameters of African American and white participants in higher and lower SES. It also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants.

DXA measures of body composition and bone mineral density are among the clinical measures acquired during participants' examinations in every wave. Body composition - the extent of lean and fat mass in various body regions - are important indicators of health. Measures of lean and fat mass are also important correlates required for thorough analyses of every domain examined by HANDLS such as risks for cardiovascular disease, diabetes, and kidney disease, changes in brain health assessed by MRI measures, and the influences of overall activity on health. Bone mineral density - a measure of bone strength - is a primary indicator of osteopenia and osteoporosis, both of which may lead to disabling bone fractures and loss of mobility.

PURPOSE AND OBJECTIVES

The purpose of this requirement is to procure quality expert services reviewing and analyzing existing Dual-energy X-ray Absorptiometry (DXA) body composition and bone mineral density data acquired on participants in the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study.

PROJECT REQUIREMENTS

I. The Contractor shall review total body, hip, and spine DXA image data provided by the Government from DXA scans acquired from HANDLS participants since 2004. Contractor shall manipulate scans revising them in diagnostic software to insure consistency in the designations of all regions of interest for each participant over time and among all participants. The goal is to define the same regions of interest within and among participants so that analyses of demographic differences and longitudinal change are assured that differences are not contaminated by differing definitions of body parts.

A) Contractor shall have licensed software and current versions of Hologic and GE Lunar software installed on workstations.

B) Contractor shall have necessary hardware and software to read data stored on legacy Iomega Zip drives.

C) Contractor shall calibrate the validity of acquired measures using standard manufacturers' phantom scans for performing quality control of the stability of DXA measures over time.

D) Contractor shall have established methods for scoring whole images as well as anatomical sub-regions for validity of measures (BMD, BMC, Fat, Lean).

E) Contractor shall have established methods for scoring the technologist avoidable errors that caused a degradation in study data quality.

F) Contractor shall establish standard operating procedures (SOP) for performing the above analysis as well as outlining the training needed for staff to perform the analysis.

G) Contractor shall have established validation data and statistical methods outlined in an SOP to document the vendor's reader accuracy and quality.

H) Contractor shall have established expert review protocol and SOP for vendor expert to periodically review performance of vendor reader.

II. Using software tools available to the Contractor or software tools supplied by DXA manufactures, the Contractor shall harmonize data acquired for the Lunar DXA with data subsequently acquired from the Hologic scanner. The goal of this requirement is to create a harmonized data file so that HANDLS investigators can examine change in body composition and bone mineral density from wave 1 for all participants. Data from Lunar scans were stored by the DXA computer in Iomega Zip drives, a technology not readily available since then. Zip drives are a removable floppy disk storage system produced by Iomega in 1994. The Contractor shall have the working means to read data nondestructively stored on Zip drives. This is particularly important because the only source for these data reside on these original Zip drives, which were the backup media for the DXA computer.

A) Contractor shall have a variety of archive technology used over the last 30 years in DXA to assure that all archived scans can be read. These media technology include Zip (100, 250, 750 MB formats), Magneto Optical, DVD, and CD drives.

B) Contractor shall be able to create new master archive storage for all GE and Hologic study compatible with manufacturer workstations, and transferable to the sponsor on hardwire-encrypted hard drives.

C) Contractor shall have demonstrable experience with the creation and use of cross-calibration equations for DXA for spine, hip, and whole body scans.

D) Contractor shall have demonstrable experience in longitudinal correction and calibration of DXA data for each of the scan types using CUSUM and existing phantom data.

III. The Contractor shall perform the following:

A. Quality control checks on all DXA image data to insure correct participant alignment in the scanner and complete image acquisition such that participants' entire bodies are included in the image. These quality control checks shall have scoring methods for each anatomical method that codes the quality problems and validity of the region.

B. Examine each DXA image to check on the appropriate location and accurate positioning of all regions of interest. The Contractor shall re-define all incorrectly located regions of interest. The Contractor shall insure the regions of interest are defined identically in all scans for each participant. Contractor shall have demonstrated experience with studies of similar size (number of participants) as well as timeframe of data acquisition.

C. The Contractor shall define a protocol for insuring consistency within and among participants' DXA scans. These procedures require a quality assurance protocol and periodic reports to the Government on the extent of consistency achieved by the Contractor's procedures.

D. Based upon the scans yielded by re-examining the regions of interest, the Contractor shall supply a data file on body composition and bone mineral density measurements with a record for each participant at each examination. These measurements shall consist of the data produced by the software provided by the DXA manufacturer and other measures provided by the Contractor that are meaningful for examining demographic differences and longitudinal change in body composition and bone mineral density. Measures shall include but shall not be limited to lean and fat mass compositions for total body, body without head, abdomen, arms, legs, and torso and bone mineral density of entire spineand the L1-L4 vertebrae of the spine, total hip and anatomical regions of the hip including neck, shaft, Ward's triangle, and trochanter, arms, legs, ribs. Additional derivations that would be useful: FRAX assessment, TBS measure, NHANES T-scores, NHANES Z-scores, cross calibrated hip axis length.

E. The Contractor shall establish procedures for continued quality control checks, re-analyses, and data generation for the on-going scans acquired during wave 5 of HANDLS.

F. Contractor shall have a track record of expertise in DXA and quality control for multisite studies as evidenced by publications in peer-reviewed journals.

REPORTS/DELIVERABLES

The following reports will be required: (1) A semi-annual report. (2) A Quality Assurance Protocol. (3) A final report shall be submitted before the expiration date of this contract. The Final Report shall be prepared in the same format as the semi-annual reports and shall include a summation of the work performed under the entire contract period of performance.

ANTICIPATED PERIOD OF PERFORMANCE

The period of performance for this acquisition will consist of one 12-month base period and three 12-month option periods.

OTHER IMPORTANT CONSIDERATIONS

The North American Industry Classification System (NAICS) Code is 621511 with a size standard of $32.5 million.

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALITY

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Contracting Office Address:

Office of Acquisition, NIDA Contracts Management Branch, Blue NIA Section

6001 Executibe Blvd., Rockville, MD 20852

Link/URL: https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA(AG)-RFQ-75N95019R00034/listing.html